Tokyo, Oct. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059366) titled 'Comparison of circuit lifespan between polysulfone and cellulose triacetate membranes during continuous renal replacement therapy' on Oct. 11.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Non-randomized
Blinding - Open -no one is blinded
Control - Active
Primary Sponsor:
Institute - Japanese Red Cross Osaka Hospital
Condition:
Condition - cute kidney injury (AKI) or chronic kidney disease (CKD), including end-stage renal disease (ESRD), requiring continuous renal replacement therapy (CRRT)
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - In Japan, five types of hemofilter membrane materials are currently available for continuous renal replacement therapy (CRRT). Each membrane material has unique characteristics, and clinicians may select them according to the patient's disease and clinical condition. One of the key considerations in membrane selection is the potential to extend circuit lifespan. CRRT is performed continuously over 24 hours; however, the replacement interval of the circuit, including the hemofilter, varies among institutions, typically every 24 or 48 hours. When circuits are used beyond 24 hours, membranes with higher antithrombogenic properties are preferred. Cellulose triacetate (CTA) membranes are known for their antithrombogenic properties, but evidence supporting their contribution to prolonged circuit lifespan remains limited. Therefore, we conducted a non-randomized comparative study at our institution to evaluate the effect of membrane material on circuit lifespan. Polysulfone (PS) membranes, which are the most commonly used in CRRT in Japan, were selected as the comparator.
Basic objectives2 - Efficacy
Intervention:
Interventions/Control_1 - For patients requiring CRRT, hemofilters with cellulose triacetate (CTA) membranes were used for the first and second day of treatment.
Interventions/Control_2 - For patients requiring CRRT, hemofilters with polysulfone (PS) membranes were used for the first and second day of treatment.
Eligibility:
Age-lower limit - 18
years-old
<=
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - The study population consisted of patients admitted to the intensive care unit of our hospital between June 2023 and September 2024, for whom the attending intensivist or primary physician determined that continuous renal replacement therapy (CRRT) was required.
Key exclusion criteria - Patients meeting any of the following criteria were excluded from the study:
Presence of significant coagulation abnormalities due to hematologic disorders.
Use of a hemofilter other than the assigned membrane material during the first or second CRRT session.
Circuit clotting caused by prolonged troubleshooting, such as device malfunction or inadequate blood flow.
Missing data regarding patient background or CRRT treatment conditions.
Target Size - 48
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2023 Year 03 Month 13 Day
Date of IRB - 2023 Year 05 Month 25 Day
Anticipated trial start date - 2023 Year 06 Month 01 Day
Last follow-up date - 2024 Year 09 Month 30 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067898
Disclaimer: Curated by HT Syndication.